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Could a 3-Day pill ease severe postpartum depression?

NCT ID NCT06285916

Symptom relief Sponsor: TWi Biotechnology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tested an experimental oral drug called NORA520 in 93 women with severe postpartum depression. Participants took the drug or a placebo for just 3 days. Researchers measured how well it reduced depressive symptoms, checked for side effects, and looked at how much of the drug gets into breastmilk. The goal is to see if NORA520 can offer a fast, short-term treatment option for new mothers struggling with severe depression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NORA520
What this could lead to
If it works, this could provide a fast-acting, short-course oral treatment for severe postpartum depression, helping new mothers feel better within days.
What could go wrong
This is an early Phase 2 trial with only 93 participants, so results may not apply to everyone. The treatment is only 3 days long, and side effects or lack of effectiveness are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

93 people

The number who actually took part.

Started

Mar 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Are willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits * Are an adult female between 18 and 45 years of age, inclusive; * Have either ceased lactating at Screening, or if still lactating or actively breastfeeding at Screening, agree to temporarily cease giving breastmilk to their infant(s) from just prior to first dose of study drug on Day 1 through Day 14; * Have a negative pregnancy test at Screening and Day 1 (prior to dosing); * Have had a depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery * Are ≤9 months postpartum at Screening. Key Exclusion Criteria: * Have a history or current diagnosis or current treatment of bipolar disorder, schizophrenia, or schizoaffective disorder; * Have had recorded treatment failure of ≥2 different antidepressant classes (e.g., SSRI, SNRI) in the current or previous episode; * Are currently experiencing active psychosis per Investigator assessment, or are taking typical or atypical antipsychotic medication; * Have a history of suicidal behavior within 2 years; * Have a history or current diagnosis of sleep apnea or narcolepsy.

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Conditions

The condition(s) this trial relates to.

Depression postpartum depression

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression, postpartum Post partum depression Post-natal depression Postnatal depression Postpartum depression

Contacts and locations

Locations

  • Advanced Research Center

    Anaheim, California, 92805, United States

  • Alliance Research Institute

    Canoga Park, California, 91304, United States

  • CenExel Clinical Research

    Decatur, Georgia, 30030, United States

  • CenExel Clinical Research

    Savannah, Georgia, 31405, United States

  • Cenexel Clinical Research

    Sherman Oaks, California, 91403, United States

  • Cenexel Clinical Research

    Torrance, California, 90504, United States

  • Cenexel Clinical Research

    Atlanta, Georgia, 30331, United States

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060, United States

  • Combined Research

    Orlando, Florida, 32807, United States

  • GCP Research

    St. Petersburg, Florida, 33607, United States

  • Insight Hospital and Medical Center Chicago

    Chicago, Illinois, 60616, United States

  • Maximos Ob/Gyn

    League City, Texas, 77573, United States

  • MedOne Clinical Research

    Miami, Florida, 33145, United States

  • Meridian International Research, Inc.

    Miami Gardens, Florida, 33014, United States

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112, United States

  • Pillar Clinical Researc

    Richardson, Texas, 75080, United States

  • Pillar Clinical Research

    Bentonville, Arkansas, 72712, United States

  • Zucker Hillside Hospital

    Glen Oaks, New York, 11004, United States

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